The mandate of the Health Protection Branch of
Health Canada is to protect the health of all Canadians. It is charged with the
responsibility of ensuring the safety and efficacy of drugs, the safety of
foods, the safety and efficacy of medical devices, the safety of radiation
emitting devices and the safety of certain consumer products. The Health
Protection Branch also has the responsibility of drafting legislation designed
to protect the public against hazardous substances. The level of safety afforded
by this system meets the demands made by the Canadian public for safe and
effective products
In order to evaluate a new product for which no
safety data exists, it must be tested. Some valid non-animal tests (e.g. tissue
culture, biochemical assays) are widely used by the Health Protection Branch and
others, as they have proven to be of value in this work. While recognizing the
need to further refine, reduce and replace animal use, in the final analysis,
new methods can never totally replace testing in an appropriate animal model.
For example, in vitro methods cannot show complex interactions of a chemical in
a living being. Indeed, the extreme complexity of the biochemical systems in
living creatures cannot be duplicated by our current knowledge, nor will it for
the foreseeable future
With regard to the much-cited LD-50 test, the
Health Protection Branch has not used the classical test as a basis for our
regulatory decision-making since 1989. We are, however, aware of the need to
assess the acute toxicity of new products prior to their introduction. There is
almost universal scientific opinion that in order to determine this, doses must
be pushed high enough to cause the death of some animals. In order to minimize
this number, toxicity limit tests, which require far fewer animals, have become
the standard means of providing this information
The Draize eye and skin irritancy test is, at
present, the only reliable means available to evaluate the safety of a substance
to be introduced into or around the eye or placed on the skin. The
responsibility for the testing of a drug, medical or radiation emitting device,
food additive or a consumer product, rests with the manufacturer or producer.
The Health Protection Branch monitors the studies undertaken, evaluates
manufacturers' submissions prior to granting marketing approval, and conducts
post-marketing surveillance of products to ensure that no unexpected problems
occur. With respect to cosmetic products, there is no requirement for pre-market
approval by the Health Protection Branch. In order to sell such a product, it is
sufficient for a manufacturer to have data available to him which shows his
products to be safe when used as directed
Studies conducted on behalf of the Health
Protection Branch are related to the safety of human health. All
projects involving the use of animals, whether the work is performed in our own
laboratories or elsewhere, are carefully screened by our veterinarians to ensure
every possible measure will be implemented to prevent suffering and to uphold
humane standards. The procedures used must be essential to the
furtherance of our mandate of protecting the health of all Canadians, there must
be no other means by which to gain the required information, and there must be
approval by our Animal Care Committee. Compliance with the high standards of
animal care and use, administered by the Canadian Council on Animal Care, is
required by all major granting agencies and government departments.
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